[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539926":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":43,"locations":52,"responsibleParty":71,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":29,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":29,"overallStatus":55,"whyStopped":29,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.",[13,14,15],"Other: High Oxidant Little Cigar","Other: Low Oxidant Little Cigar","Other: Usual Cigarette",{"label":17,"type":10,"description":18,"interventionNames":19},"Group B","Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Group C","Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.",[13,14,15],[25,30,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"High Oxidant Little Cigar","Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.",[9,17,21],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Low Oxidant Little Cigar","Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.",[9,17,21],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Usual Cigarette","Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.",[9,17,21],[39],{"name":40,"affiliation":41,"role":42},"Joshua Muscat, Ph.D.","Penn State Hershey College of Medicine","PRINCIPAL_INVESTIGATOR",[44,48],{"name":40,"role":45,"phone":46,"phoneExt":29,"email":47},"CONTACT","7175318521","jmuscat@pennstatehealth.psu.edu",{"name":49,"role":45,"phone":50,"phoneExt":29,"email":51},"Kenneth Houser, MS","7175315473","khouser@pennstatehealth.psu.edu",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Penn State College of Medicine","RECRUITING","Hershey","Pennsylvania","17033","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-76.65025,40.28592,{"lat":65,"lon":64},[68,69],{"name":49,"role":45,"phone":50,"phoneExt":29,"email":51},{"name":70,"role":42,"phone":29,"phoneExt":29,"email":29},"Joshua Muscat, PhD",{"type":42,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":74,"oldNameTitle":29,"oldOrganization":29},"Joshua Muscat","Professor, Department of Public Health Sciences","Penn State University",[76],{"name":77,"class":78},"National Institute on Drug Abuse (NIDA)","NIH","100539926","little-cigar-oxidants-100539926",false,"NCT06310187","Little Cigar Oxidants","Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars","Inclusion Criteria:\n\n1. Aged 21 - 65 years old\n2. Daily cigarette smoker (\\>= 1 cigarette per day);\n3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter\n4. No current or past use of Little Cigars\n5. All other forms of nicotine must be used \\\u003C6 days out of the past 30 days.\n6. Able to read and write in English\n7. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days\n8. No plan to quitting smoking in the next 3 months\n\nExclusion Criteria:\n\n1. Women who are pregnant and\u002For nursing or trying to become pregnant\n2. Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)\n3. Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV\u002FAIDS, multiple sclerosis symptoms) or any medical disorder\u002Fmedication that may affect participant safety or biomarker data\n4. Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months\n5. Exhaled Carbon Monoxide (CO) measurement of \\>= 17 parts per million","ALL","21 Years","65 Years",{"count":90,"type":91},50,"ESTIMATED","INTERVENTIONAL",[94],"NA","Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.",[97,98],"Tobacco Use","Oxidative Stress","2026-06-12",{"date":101,"type":102},"2026-06-16","ACTUAL",{"date":104,"type":102},"2026-03-25",{"date":106,"type":91},"2029-08",{"name":5,"class":6},1]